IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers

Multiple Myeloma Clinical Trial

Official title:

Phase 1/2 Study of IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06119685
• Other study ID #: Indapta-Trial-1
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 25, 2023
• Est. completion date: December 31, 2029

Study information

• Verified date: November 2023
• Source: Indapta Therapeutics, INC.
• Contact: Indapta Therapeutics, Inc.
• Email: TRIALS[@]INDAPTA.COM
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open label, Phase 1/2, first-in-human, multiple ascending dose, and dose-expansion study of IDP-023 administered as a single agent and in combination with or without interleukin-2 (IL-2), and with or without daratumumab or rituximab to evaluate the safety, tolerability and preliminary antitumor activity in patients with advanced hematologic cancers.

Description:

IDP-023 is an off-the-shelf, allogeneic cell product made of "natural killer" cells, also called NK cells. White blood cells are part of the immune system and NK cells are a type of white blood cell that are known to kill cancer cells.

This is an open label, Phase 1/2, first-in-human, multiple ascending dose, and dose-expansion study of IDP-023 administered as a single agent and in combination with or without interleukin-2 (IL-2), and with or without daratumumab or rituximab to evaluate the safety, tolerability, and preliminary antitumor activity in patients with relapsed and/or refractory advanced multiple myeloma (MM) or non-Hodgkin's lymphoma (NHL), respectively.

The study is divided into a phase 1 dose escalation phase and a phase 2 expansion phase.

Phase 1 (Escalation Phase): The primary objectives of Phase 1 are to define the safety of different IDP-023 containing regimens and to define the recommended regimen and Phase 2 doses (RP2D) of IDP-023.

Phase 2 (Expansion Phase): The objective of the Phase 2 expansion cohort is to evaluate the safety and efficacy of IDP-023 in advanced MM in combination with daratumumab and advanced NHL in combination with rituximab.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: December 31, 2029
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• For MM patients: Documented diagnosis of MM requiring systemic therapy and relapsed and/or refractory (R/R) disease after = 3 prior lines of therapy.

• For NHL patients: R/R disease and failed = 2 lines of systemic chemotherapy.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Life expectancy of greater than 12 weeks per the Investigator.

Key Exclusion Criteria:

• Impaired cardiac function or history of clinical significant cardiac disease.

• Human immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.

• Active SARS-CoV-2 infection.

• Has untreated central nervous system, epidural tumor metastasis, or brain metastasis.

Related Conditions & MeSH terms

• Blood Cancer
• Hematologic Neoplasms
• Lymphoma
• Lymphoma, Non-Hodgkin
• Multiple Myeloma
• Neoplasms, Plasma Cell
• NHL
• Refractory Multiple Myeloma
• Refractory Non-Hodgkin Lymphoma
• Relapsed Multiple Myeloma
• Relapsed Non-Hodgkin Lymphoma

Intervention

Drug:
• IDP-023
NK cell therapy
• Rituximab
Anti-CD20 antibody therapy
• Daratumumab
Anti-CD38 antibody therapy
• Interleukin-2
Immune cytokine
• Cyclophosphamide
Lymphodepleting chemotherapy
• Fludarabine
Lymphodepleting chemotherapy
• Mesna
Chemoprotectant

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia
United States	University Hospitals Cleveland	Cleveland	Ohio
United States	NEXT Oncology Virginia	Fairfax	Virginia
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Florida Cancer Specialists and Research Institute - Lake Mary Cancer Center	Lake Mary	Florida
United States	University of Minnesota	Minneapolis	Minnesota
United States	SCRI Oncology Partners	Nashville	Tennessee
United States	NYP/Weill Cornell Medical Center	New York	New York
United States	Providence Cancer Institute Franz Clinic	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Stanford University	Stanford	California
United States	Atrium Health Wake Forest Baptist	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Indapta Therapeutics, INC.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1)	Escalation Period	1 year
Primary	Incidence of dose-limiting toxicities (DLTs) of IDP-023 Monotherapy - (Phase 1)	Escalation Period	up to 21 days
Primary	Nature of dose-limiting toxicities (DLTs) of IDP-023 Monotherapy - (Phase 1)	Escalation Period	up to 21 days
Primary	Incidence of dose-limiting toxicities (DLTs) of IDP-023 in combination with Daratumumab or Rituximab - (Phase 1)	Escalation Period	up to 35 days
Primary	Nature of dose-limiting toxicities (DLTs) of IDP-023 in combination with Daratumumab or Rituximab - (Phase 1)	Escalation Period	up to 35 days
Primary	Maximum tolerable dose (MTD) or a tolerated dose below MTD - (Phase 1)	Escalation Period	1 year
Primary	For MM: Anti-tumor activity by objective response rate (ORR), complete response (CR), stringent complete response (sCR), very good partial response (VGPR), and partial response (PR) - (Phase 2)	Expansion period	2 years
Primary	For NHL: Anti-tumor activity by objective response rate (ORR) - (Phase 2)	Expansion period	2 years
Secondary	PK (Cmax) of IDP-023 - (Phase 1/2)	Escalation and expansion periods	2 years
Secondary	PK (AUC) of IDP-023 - (Phase 1/2)	Escalation and expansion periods	2 years
Secondary	For MM: Anti-tumor activity by objective response rate (ORR), complete response (CR), stringent complete response (sCR), very good partial response (VGPR), and partial response (PR) - (Phase 1)	Escalation period	1 year
Secondary	For NHL: Anti-tumor activity by objective response rate (ORR) - (Phase 1)	Escalation period	1 year
Secondary	Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 2)	Expansion period	2 years